When the fields of intellectual property law and biotechnology intersect, most analysis is driven byeconomic and ethical issues. This article examines these factors, but in relation to the emerging security threat posed by biohackers, or do-it-yourself (“DIY”) scientists, who operate free fromoversight and industry norms at the fringes of the biotechnology community. Public health risks are poised to grow as these citizen-scientists race for lucrative discoveries in the new frontier of syntheticbiology. This article proposes that the existing paradigm adjust accordingly to leverage regulatory compliance from the most ambitious biohackers looking to benefit from patent protection. The U.S. government could bring aspiring entrepreneurial biohackers into the fold by making non-institutional patent applicants undergo Center for Disease Control biosafety training, personnelscreening, and lab registration one year prior to receiving patent application eligibility in order toreduce some of the potential risk of these unmonitored labs present.
Brian J. Gorman, Patent Office as Biosecurity Gatekeeper: Fostering Responsible Science and Building Public Trust in DIY Science, 10 J. Marshall Rev. Intell. Prop. L. 423 (2011)